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Esophageal Cooling During Ablation for Atrial Fibrillation (IMPACT II Trial)
IMPACT II Trial Summary
This trial will test if a cooling probe can protect the oesophagus during ablation, reducing the risk of severe oesophageal damage in AF patients.
IMPACT II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowIMPACT II Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.IMPACT II Trial Design
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Who is running the clinical trial?
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- I am between 18 and 85 years old.I am approved for and waiting for AF ablation treatment under general anesthesia.I am unable to give consent for medical procedures.You cannot have the follow-up endoscopy for any reason.You have a history of bleeding in your upper digestive system or have conditions that make it unsafe to perform procedures in your esophagus.
- Group 1: Study group
- Group 2: Control group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research trial have an age restriction, specifically for those over 65?
"For this clinical trial, only participants of legal age and under 85 years old can be recruited."
Is recruitment currently ongoing for this trial?
"As listed on clinicaltrials.gov, the recruitment of participants for this study is currently underway. This experimental trial was first opened to public scrutiny on March 10th 2022 and has recently been updated with new information as of February 15th 2023."
What is the aggregate number of clinical centers administering this trial?
"Several clinical trial sites are offering this medication, such as the Beth Israel Deaconess Medical Center in Boston, University of Pennsylvania in Philadelphia, and Texas Cardiac Arrhythmia Research Foundation in Austin. An additional 5 locations can also be found across America."
Can I sign up for this experiment?
"This medical trial seeks to recruit 500 individuals, aged between 18 and 85 years old, who are currently suffering from atrio-esophageal fistula. In addition, they must meet the necessary requirements for AF ablation treatment (general anaesthesia) as indicated by international standards. Moreover, participants must have already decided on undergoing this procedure prior to joining the study."
What is the current count of participants in this clinical experiment?
"This trial, managed by Advanced Cooling Therapy Inc. (Attune Medical), requires 500 patients who meet the pre-set qualifications to be recruited from a range of medical centres - such as Beth Israel Deaconess in Boston and University of Pennsylvania in Philadelphia."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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